Medicinesauthority.gov.mt2

Us er information, pleas e read carefully!G . P OHL -B OS K A MP G mbH & C o.,K ieler S traß
e 1 1, D-25551 Hohenlockstedt, G ermany
S pray 0.4 mg /dos e
Active ingredient: glyceryl trinitrate
C ompos ition: 1 puff of the s pray contains 0.4 mg glyceryl trinitrate. Other cons tituents : medium-chaintriglycerides, medium-chain partial glycerides, absolute ethanol, peppermint oil.
Indications :Ð Treatment of all forms of episodic cardiac pain (relief of angina pectoris attacks);Ð As a prophylactic measure immediately prior to physical exertion or other situations known from experience
to be capable of triggering episodic cardiac pain (prophylaxis of angina pectoris);
Ð Acute cardiac infarction;Ð Acute left-heart failure (acute myocardial insufficiency, with acutely impaired left ventricular function);Ð C atheter-induced coronary spasms during coronary angiography.
C ontraindications :G lyceryl trinitrate must not be used in patients with:Ð Hypersensitivity to one of the components of the drug;Ð Acute circulatory failure (shock, circulatory collapse);Ð S evere hypotension (systolic blood pressure below 90 mm Hg);Ð C ardiogenic shock, unless intra-aortic counterpulsation or positively inotropic drugs ensure an adequately
high left-ventricular end-diastolic pressure;
Ð Myocardial disorders, with a reduction of the heart volume (hypertrophic obstructive cardiomyopathy);Ð C onstrictive pericarditis;Ð P ericardial tamponade;Ð P atients with primary pulmonary hypertens ion (high blood pres s ure in the pulmonary circulation of
unknown causation), since a possible increase in the blood supply to hypoventilated alveolar regions(hypoventilated regions of the lungs) can lead to hypoxaemia (reduction in the oxygen concentration in thearterial blood). T his applies in particular to patients with disturbances of the blood flow in the coronaryvessels (coronary heart disease).
Ð Due to a considerable increase in the hypotensive effect and the resulting severe side effects (e.g. syn-
copes, myocardial infarction), sildenafil (Viagra) may not be given additionally to an existing therapy withnitric oxide donors (e.g. Nitrolingual¨ -S pray).
E specially careful medical supervision is required in patients with:Ð Acute cardiac infarction with low filling pressures. Nitrolingual¨ -S pray must always be used with caution in
such cases; a reduction of the systolic blood pressure to below 90 mm Hg must be avoided.
Ð Aortic and/or mitral stenosis;Ð A tendency to disturbances of regulation of the circulation due to hypotension (orthostatic disturbances of
circulatory regulation);
Ð Diseases associated with increased intracranial pressure (further elevation of the blood pressure has so
far been observed only in association with high-dose i.v. administration of glyceryl trinitrate).
During pregnancy and breastfeeding, as an extra precaution glyceryl trinitrate must only be taken if expresslydirected by the doctor. E xperiments in animals have yielded no evidence of damage to the foetus.
S ide effects :Headache (nitrate-induced headache) is common at the start of the treatment. E xperience has shown thatthis usually subsides as administration of the substance is continued.A decline in the blood pressure and/or orthostatic hypotension have occasionally been observed when thesubstance is first used, and also when the dose is increased. T his may be associated with a reflex increasein the heart rate, drowsiness and a sensation of dizziness and weakness.Nausea, vomiting, transient reddening of the skin (flush) and allergic cutaneous reactions may occur in rarecases.C ollaps e s tates are obs erved in rare cas es , occas ionally with bradycardial dis turbances of heartrhythm, and syncope. E xfoliative dermatitis may occur in individual cases.In rare cas es , a pronounced decline in the blood pres s ure may be linked to increas ed s everity of thesymptoms of angina pectoris.Tolerance development and the occurrence of cros s tolerance to other nitro compounds have beendescribed. Attenuation of the haemodynamic effects has been observed within 24 h, even during continuousadministration.E ven when used as directed, this drug may alter the reactions to such an extent that the ability to drive oroperate machinery is impaired. T his applies in particular when the effects are combined with alcohol.
Interactions with other drugs :T he following interactions of this drug must be borne in mind:T he simultaneous ingestion of other vasodilators, substances which lower the blood pressure (antihyperten-sives), -blockers, calcium antagonists, neuroleptics or tricyclic antidepressants, and alcohol may potentiatethe hypotensive action of Nitrolingual¨ -S pray.C oncomitant intake of nitric-oxide-donors (e.g. Nitrolingual¨ -S pray) and s ildenafil (Viagra) enhances thehypotens ive effect. T herefore the concomitant adminis tration of nitric-oxide-donors , e.g. the activeingredients of Nitrolingual¨ -S pray, and Viagra, is contra-indicated (see contra-indications).If a patient treated with sildenafil (Viagra) needs a rapidly effective nitrate (e.g. in case of an acute anginapectoris attack) he/she must be hospitalised immediately.In patients previously treated with organic nitrates (e.g. isosorbide dinitrate, isosorbide-5-mononitrate), ahigher dose of glyceryl trinitrate may be necessary to achieve the desired haemodynamic effect. During thesimultaneous use of dihydroergotamine, Nitrolingual¨ -S pray may lead to an increase in the DHE level andthus potentiate its hypertensive action. When heparin and glyceryl trinitrate are used simultaneously theeffects of heparin are reduced.
Dos age guideline: Unless otherwise prescribed, at the start of an angina pectoris attack or immediatelybefore exercise known from experience to be capable of triggering an attack of angina pectoris, dependingon the severity 0.4 mg - 0.8 mg glyceryl trinitrate is administered, corresponding to 1-2 puffs of the spray. Inpatients with acute left-heart failure or acute cardiac infarction, while monitoring the circulatory parameters(systolic blood pressure in excess of 100 mm Hg) 0.4 mg - 1.2 mg glyceryl trinitrate is administered dependingon the severity, corresponding to 1-3 puffs of the spray. If there is no response after 10 min the treatment maybe repeated at the same dose. F or prophylaxis prior to coronary angiography, 0.4 mg - 0.8 mg glyceryltrinitrate is administered, corresponding to 1-2 puffs of the spray.
Nature and duration of us e: B efore each use, remove the protective cap by pulling it off in a verticallyupwards direction. To familiarise oneself with the use of Nitrolingual¨ -S pray and to fill the dose-meteringchamber completely when first using, the valve is first of all operated once and the contents sprayed into theair (press the spray nozzle down smoothly as far as it will go, and then release). T his may also be necessaryif the spray has not been used for a long time. T he spray is now ready to use, and needs not to be shakenfirst.When spraying, hold the bottle vertically with the spray nozzle uppermost. P osition the orifice in the spraynozzle as close as possible to the mouth. T his orifice is easily felt, and can therefore also be used as areliable indicator of the bottle orientation when using the substance at night. T he spray is puffed into themouth, preferably under the tongue, at intervals of about 30 sec while holding the breath. Do not inhale.
G eneral information: T he transparent container can be used for continuous monitoring of the consumption.A new Nitrolingual¨ -S pray should be obtained in good time, before the end of the delivery tube is no longercovered by the fluid level. As with all other sprays, there is a residual volume of fluid at the bottom of thebottle which cannot be used. Nitrolingual¨ -S pray must not be used after the expiry date. Do not force openor burn after use. Do not spray on to naked flames or incandescent objets.
K eep all medicines out of the reach of children.
S tatus: November 1998

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